CFDA uncovers the amazing black curtain of drug registration

Reporters found that in the "blacklist" disclosed by CFDA that night, Boji medicine (300404), a new member of gem, was involved Shanghai Pharmaceutical (601607), another A-share company, was also affected The tip of the iceberg of application for drug registration in China is being unveiled Generally speaking, the new drug products that are finally sold to patients need to go through layers of tests and checks, and all the data can be put on the market only when they meet the relevant standards But it's hard for people to think of it, and the agencies responsible for the inspection will also fake it On the evening of December 7, the State Food and Drug Administration (CFDA) released the second batch of results of self inspection and verification on its official website, with 14 drug companies and 13 varieties "killed" CFDA said frankly that the above 13 drug registration applications have the problems of untrue and incomplete clinical trial data Therefore, according to the relevant provisions of the measures for the administration of drug registration, the above 13 drug registration applications are not approved It is worth mentioning that CFDA's announcement also exposed various dark scenes of drug registration applications Among them, the contract research organization (CRO), as the outsourcing service of pharmaceutical R & D, also plays an important role The so-called cro is a specialized research institution or company that undertakes a certain part of the research and development of new drugs The 21st century economic news reporter found that in the "blacklist" disclosed by CFDA that night, Boji Pharmaceutical (300404 SZ), a new gem player, was involved Shanghai Pharmaceutical (601607 SH), another A-share company, was also affected Bogey medical contract research suspected of fraud According to the announcement disclosed by CFDA on that night, in the registration application of eplidone tablet (acceptance No.: cxhs1400017) and eplidone capsule (acceptance No.: cxhs1400018) applied by Shenzhen Nanfang Yingxin Pharmaceutical Co., Ltd and Hefei Jiunuo Pharmaceutical Technology Co., Ltd., the clinical trial organization of the drug is 458 Hospital of the people's Liberation Army, and the biological sample analysis unit is Guangzhou psychiatric hospital Hospitals, and contract research organizations are Boji medicine Similarly, in the drug registration of paracetamol tramadol capsule (acceptance No.: cxhs1200035) applied by Wuxi Fuji Pharmaceutical Co., Ltd and Guangdong Aimin Pharmaceutical Co., Ltd., its clinical trial organization and biological sample analysis unit are Guangzhou Psychiatric Hospital, and the contract research organization is Boji pharmaceutical According to the public information, Boji pharmaceutical, which landed on the gem on April 24 this year, is a professional cro service provider, which mainly provides pharmaceutical enterprises and other new drug R & D institutions with a full range of new drug R & D outsourcing services The company's main business covers all stages of new drug research and development, including clinical research services, preclinical research services, technology transformation services, other consulting services and preclinical independent research and development, etc it claims to be a new high-tech enterprise that can provide a full range of one-stop cro services According to CFDA's disclosure that night, the clinical trials of eplidone tablets and eplidone capsules were entrusted by Boji medicine The main links of the clinical process of the project are implemented by the company's staff, such as physical examination, clinical process observation, blood collection, sample processing, handover and distribution of experimental drugs, blood sample in and out of the warehouse, etc However, according to the signature form of the researcher of eplidone tablet project, except for Zhang Mou, the main researcher of the applicant (I deny participating in the project), and Cheng Mou, a clinical observer, the other participants were all the staff of Boji medicine, while the clinical observer did not understand the process of the trial, and all the original records of the trial were signed by him At the same time, most of the clinical trial records show that: the clinical trial drug administration and blood collection record form, the sample in and out of storage registration form, the trial drug registration form, the trial drug requisition registration form, etc are signed by Boji pharmaceutical staff In addition, during the application process, the receiving records of biological samples lack information such as sample identification, quantity, transfer mode and condition, sample status, etc.; the stored biological samples have no original records of receiving and storing; the original experimental records of biological samples detection lack information such as experimental conditions, process and experimental results of each batch; the test data cannot be traced; the clinical trials have been conducted During the process, the original record was missing; the X-ray examination data could not be traced; the name of the atlas file was not related to the corresponding blood sample number; the abandoned test data and modified data were concealed Similarly, there are many problems in the application for the registration of paracetamol and tramadol capsules, such as the data can not be traced, the data of the abandoned test are concealed, and the data of the modified test are modified In this regard, a person with deep knowledge and industry said, "the self inspection and verification of drug registration exposed the lack of credibility in the industry Pharmaceutical companies and cros should take the main responsibility for the problems Pharmaceutical companies are naturally to blame, but whether cro is an 'accomplice' or 'culprit' should also be investigated to the end The person said helplessly that the reality is that Chinese drug clinical trials are really too cheap Two bioequivalence and one big clinical trial add up to only a few million "Can such a low price produce high-quality test results? We cannot but say that the quality of drug test data is low." On the night Shanghai Pharmaceutical was affected, CFDA also said it would investigate four medical institutions Among them, the Second Affiliated Hospital of Suzhou University was put on file for investigation on suspected fraud, and the clinical trial data of other drugs it undertook were also extended for examination, and the relevant contract research organizations were also extended for examination In addition, Hunan Tiger Xiangya Pharmaceutical Research Co., Ltd was put on file by Hunan food and Drug Administration for investigation; the drug clinical trial data of the First Affiliated Hospital of the Fourth Military Medical University of the people's Liberation Army was suspected of fraud, and the illegal behavior of the clinical trial ward custody of the 458 Hospital of the people's Liberation Army was transferred to the General Logistics Department of the people's Liberation Army The Ministry of health filed a case for investigation According to the above announcement, in the clinical trial data of aspirin sustained-release tablets (acceptance No.: cyhs1190075) applied by Changzhou Pharmaceutical Factory Co., Ltd., the applicant is Changzhou Pharmaceutical Factory Co., Ltd., the clinical trial organization and biological sample analysis unit are the Second Affiliated Hospital of Suzhou University, and the contract research organization is Shanghai kairuis Biotechnology Co., Ltd But the test drug is not true Both the test preparation and the reference preparation are test preparation, the package specification is 20 pieces / plate, and the commercial package specification of the reference preparation is 24 pieces / plate However, the sample retained on site shows that the package specification and the tablet appearance of the reference preparation are completely consistent with the test preparation In addition, it has the problem of selective use of data On November 9, 2010, the trace file showed that sample 13-Ⅱ-8-0 (steady-state trough value of multiple administration) was tested twice in the same batch, and the data difference between the two times was large, so the second test data was used, without explanation; on November 7, 2010, the trace file showed that there were test records of sample 15-i-1-0-2 in the blood sample test of subject 15, but the data was not used, and no relevant original record was found It is worth noting that Changzhou Pharmaceutical Co., Ltd is a subsidiary of Changzhou Pharmaceutical Co., Ltd., a core enterprise of Shanghai Pharmaceutical Which companies are involved in the forgery, whether there is any forgery in Boji pharmaceutical's IPO, whether there are other types of related matters in Shanghai pharmaceutical, and the determination of punishment by the regulatory authorities for related acts, our reporter will continue to pay attention to.